Purpose To provide recommendations on the appropriate use of breast tumor biomarker assay results to guide decisions on systemic therapy for metastatic breast cancer. Methods A literature search and prospectively defined study selection identified systematic reviews, meta-analyses, randomized controlled trials (RCTs), prospective–retrospective studies, and prospective comparative observational studies published from 2006 through September 2014. Results The literature search revealed 17 articles that met criteria for further review: 11 studies reporting discordances between primary tumors and metastases in expression of hormone receptors or human epidermal growth factor receptor 2 (HER2), one RCT that addressed the use of a biomarker to decide whether to change or continue a treatment regimen, and five prospective–retrospective studies that evaluated the clinical utility of biomarkers. Recommendations In patients with accessible metastases, biopsy for confirmation of disease process and retesting of estrogen receptor, progesterone receptor, and HER2 status should be offered, but evidence is lacking to determine whether changing anticancer treatment on the basis of change in receptor status affects clinical outcomes. With discordance of results between primary and metastatic tissues, the Panel consensus is to use preferentially the estrogen receptor, progesterone receptor, and HER2 status of the metastasis to direct therapy if supported by the clinical scenario and patient's goals for care. Carcinoembryonic antigen, cancer antigen 15-3, and cancer antigen 27-29 may be used as adjunctive assessments, but not alone, to contribute to decisions regarding therapy. Recommendations for tumor rebiopsy and use of circulating tumor markers are based on clinical experience and Panel informal consensus in the absence of studies designed to evaluate the clinical utility of the markers. As such, it is also reasonable for clinicians to not use these markers as adjunctive assessments.

Adjuvant therapy improves breast cancer survival but is underutilized by Black women. Few interventions have addressed this problem. This preliminary report describes the process we used to develop a decision support intervention for Black women eligible for adjuvant therapy. Aims were to use qualitative methods to describe factors that influence Black women’s adjuvant therapy decisions, use these formative data to develop messages for a treatment decision-support intervention, and pilot test the acceptability and utility of the intervention with community members and newly diagnosed women. Thirty-four in-depth interviews were conducted with breast cancer patients in active treatment, survivors and cancer providers to gather qualitative data. Participant ages ranged from 38 to 69 years. A cultural framework was used to analyze the data and to inform intervention messages. Most women relied on their providers for treatment recommendations. Several women reported problems communicating with providers and felt unprepared to ask questions and discuss adjuvant treatment options. Other factors related to treatment experiences were: spiritual coping, collectivism, and sharing breast cancer experiences with other Black survivors. Using these formative data, we developed an intervention that is survivor-based and includes an in-person session which incorporates sharing personal stories, communication skills training and decision support. Intervention materials were reviewed by community members, researchers/clinicians and patients newly diagnosed with breast cancer. Patients reported satisfaction with the intervention and felt better prepared to talk with providers. The intervention will be tested in a randomized trial to enhance decision support and increase use of indicated adjuvant treatment.